REPLIGEN XCell ATF 2 - EU Declaration of Conformity

XCell® ATF 2 and 4 Stainless Steel Housings
User Guide
22
SG-SSATF24 rev 1
8. Appendix 3: Safety, Handling, and Conformity Information
8.1 Safety
• Repligen XCell® ATF System is rated for acceptable sound levels (60 dBA).
• Complete system visual inspection for damage or potential risk to the operator, surrounding
personnel, or equipment on a semi-annual basis.
Annual safety inspection and maintenance.
• Conduct a vacuum system leak assessment.
• Replace the air filter between the XCell® ATF Device and the XCell® Lab Controller.
• Inspect air and vacuum connections.
• Inspect the XCell® ATF Device housing components, especially the internal and sealing
surfaces for damage, rust, cracks, scoring.
• Perform a pressure hold test of the XCell® ATF Device.
8.2 Handling Instructions
TRANSPORTATION:
The Pneumatic Enclosure weighs 20 kg (44 lbs). Care
should be taken when lifting and transporting and use of
a cart is recommended.
VOLTAGE: The XCell® ATF 4 Device, has been assessed for CE regulations under the
current applicable Machinery Directives such as Essential Health and Safety
Requirements, the Low Voltage Directive, and the Electromagnetic
Compatibility Directive and the Pressure Equipment Directives. Please refer
to the Declaration of Conformity letter included with the equipment.
NOTE:
The XCell® ATF 2 Device, and XCell® ATF 4 Device have been assessed for CE
regulations under the current applicable Machinery Directives such as Essential
Health and Safety Requirements, the Low Voltage Directive, and the
Electromagnetic Compatibility Directive and the Pressure Equipment Directives.
Please refer to the Declaration of Conformity letter included with the
equipment.
8.3 Conformity
8.3.1 EU Declaration of Conformity
The XCell® Device has been assessed for CE regulations, refer to Declaration of Conformity provided
with the Device for details.
The XCell® ATF Device has been marked legibly and indelibly with following information:
Name and address of the manufacturer
• The serial number
• Designation of series or type
• CE mark
• Year of construction
• The weight of the equipment